Prospective, randomised, controlled, double-blind study to investigate the postoperative pain course following LAVH – Comparison of the application of heated, humidified CO2 insufflation gas and standard CO2 insufflation gas to maintain the integrity of the pneumoperitoneum

• Conditions: Patients with benign uterine conditions which require laparoscopic assisted vaginal hysterectomy; D25; Leiomyoma of uterus

• Registration Number: DRKS00003853
• Lead Sponsor: Pius-Hospital Oldenburg,Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie

Brief Summary

Background: We tested the hypothesis that warm-humidified carbon dioxide (CO2) insufflation would reduce postoperative pain and morphine requirement compared to cold-dry CO2 insufflation. Methods: A double-blinded, randomized, controlled trial was conducted to compare warm, humidified CO2 and cold-dry CO2. Patients with benign uterine diseases were randomized to either treatment (n = 48) or control (n = 49) group during laparoscopically assisted vaginal hysterectomy. Primary endpoints of the study were rest pain, movement pain, shoulder-tip pain, and cough pain at 2, 4, 6, 24, and 48 hours postoperatively, measured by visual analogue scale. Secondary outcomes were morphine consumption, rejected boli, temperature change, recovery room stay, and length of hospital stay. Results: There were no significant differences in all baseline characteristics. Shoulder-tip pain at 6 h postoperatively was significantly reduced in the intervention group. Pain at rest, movement pain, and cough pain did not differ. Total morphine consumption and rejected boli at 24 h postoperatively were significantly higher in the control group. Temperature change, recovery room stay, and length of hospital were similar. Conclusions: Warm, humidified insufflation gas significantly reduces postoperative shoulder-tip pain as well as morphine demand. This trial is registered with Clinical Trial Registration Number DRKS00003853 (German Clinical Trials Register (DRKS)).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Study Completion: 2013-01-19
• Results First Posted: 2015-01-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

Patients aged 18 years and over, Patient suffers from a benign metropathy,Patient has had at least one vaginal delivery, Sonographic estimation of uterus weight below 400g, Preoperative estimation of surgery time between 1-2 h, Patients must be able to give their consent and must understand the risks associated with a participation in the study

Exclusion Criteria

Preoperative estimation of uterus weight over 400g, Previous surgeries in the case history and resulting suspicion of existing extensive adhesions, Longitudinal laparotomy in the case history, Current oncological disease, Simultaneous chronic disease that requires the continuous intake of analgesics, Simultaneous participation in another clinical trial, Intake/Application of inadmissible concomitant medication/therapy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain development after 2, 4, 6, 24, 48 hours (data collection with VAS (Visual analogue scale))

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesic consumption, Body temperature prior to, during and after surgery, Length of time spent in the recovery room, Duration of inpatient stay <br>